At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 461 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Golimumab 50 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, a Fully Human Anti-TNFa Monoclonal Antibody, Administered Subcutaneously in Subjects With Active Rheumatoid Arthritis and Previously Treated With Biologic Anti- TNFa Agent(s)
In Brief
A Phase 3 clinical trial evaluating Placebo, Golimumab 50 mg, and 1 other intervention for Arthritis, Rheumatoid. Completed, enrolled 461 participants across 77 sites in 10 countries.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of golimumab (CNTO 148) in subjects who have active rheumatoid arthritis and have been treated previously with at least 1 dose of a biologic anti-TNFa agent (etanercept, adalimumab or infliximab).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesAustralia, Austria, Canada, Finland, Germany, Netherlands, New Zealand, Spain, United Kingdom, United States
CollaboratorsSchering-Plough
Timeline
Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2006
First PostedMar 2006
Primary CompletionAug 2007
Study CompletionMay 2012
TodayJul 2026
First PostedMar 7, 2006
Enrollment StartFeb 1, 2006
Primary CompletionAug 1, 2007
Study CompletionMay 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 20.3 years ago
Interventions
Placebodrug
SC injections
Golimumab 50 mgbiological
SC injections
Golimumab 100 mgbiological
SC injections